Recent Advances in Gastrointestinal Cancers

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1 Recent Advances in Gastrointestinal Cancers Ursina R. Teitelbaum, MD Section of Hematology/Oncology Abramson Cancer Center PENN 2016 Updates in Oncology June 23, 2016

2 none Disclosures

3 ASCO 2016 Highlights: Practice Change 2016 Practice Change 2017 Practice Consideration Expansion of MSI deficient histologies Immunotherapy Potential in Rare but Real Cancer

4 ASCO 2016 Highlights: Practice Change 2016 ESPAC 4 - adjuvant GEM CAP Practice Change 2017 Practice Consideration Expansion of MSI H deficient histologies Immunotherapy Potential in Rare but Real Cancer

5 Slide 1 Presented By John Neoptolemos at 2016 ASCO Annual Meeting

6 Slide 7 Presented By John Neoptolemos at 2016 ASCO Annual Meeting

7 Tumour Pathology Presented By John Neoptolemos at 2016 ASCO Annual Meeting

8 Reported Toxicity Presented By John Neoptolemos at 2016 ASCO Annual Meeting

9 Slide 20 Presented By John Neoptolemos at 2016 ASCO Annual Meeting

10 ESPAC 4 Conclusions Median survival better with GEMCAP 28 months vs 25.5 months 5 year Overall Survival favored GEMCAP over GEM 28.8 months vs 16.3 months Acceptable toxicity profile

11 ESPAC 4 Conclusions Combination cytotoxic chemotherapy is now a standard Await results of APACT and PRODIGE GemCap control arm for future adjuvant therapy trials? New adjuvant standard of care for resected pancreas cancer

12 ASCO 2016 Highlights: Practice Change 2016 Practice Change 2017 Netter-1 Phase III PRRT for midgut NET Practice Consideration Expansion of MSI H histologies Immunotherapy Potential in Rare but Real Cancer

13 NETTER-1 Phase III: Progression-Free Survival, Radiographic Response and Preliminary Overall Survival Results in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate Presented By Jonathan Strosberg at 2016 ASCO Annual Meeting

14 Midgut Carcinoid Tumors Limited therapeutic options for carcinoid tumors (midgut 25-40% of all NET) Somatostatin Analogs Everolimus Radiant 4 PRRT extensive experience in Europe

15 What is PRRT Peptide Receptor Radionuclide Therapy Cell targeting peptide (Octreotide) is combined with radionuclide (Lu 177 or Y90) Octreotide + Radionuclide = Radiopeptide Radiopeptide injected into bloodstream Binds to neuroendocrine tumor cells Delivers high dose radiation to the NET

16 Slide 4 Presented By Jonathan Strosberg at 2016 ASCO Annual Meeting

17 Main Inclusion Criteria Presented By Jonathan Strosberg at 2016 ASCO Annual Meeting

18 Slide 11 Presented By Jonathan Strosberg at 2016 ASCO Annual Meeting

19 Netter-1 Conclusions Significant increase in PFS not yet reached for 177-LU-Dotatate vs 8.4 months for Octreotide ORR 18% vs 3% Interim Analysis suggests OS benefit Safety profile favorable At FDA now Penn 2017

20 Slide 18 Presented By Stephen Chan at 2016 ASCO Annual Meeting

21 ASCO 2016 Highlights: Practice Change 2016 Practice Change 2017 Practice Consideration CALGB/SWOG Expansion of MSI deficient histologies Immunotherapy Potential in Rare but Real Cancer

22 Impact of primary tumor location on<br /> Overall Survival and Progression Free Survival <br />in patients with metastatic colorectal cancer: <br /> Analysis of CALGB/SWOG (Alliance) Presented By Alan Venook at 2016 ASCO Annual Meeting

23 CALGB/SWOG Presented By Alan Venook at 2016 ASCO Annual Meeting

24 Slide 4 Presented By Alan Venook at 2016 ASCO Annual Meeting

25

26 Embryology: The origin of the colon Presented By Alan Venook at 2016 ASCO Annual Meeting

27 Slide 8 Presented By Alan Venook at 2016 ASCO Annual Meeting

28 80405: Overall Survival by Sidedness Presented By Alan Venook at 2016 ASCO Annual Meeting

29 80405: OS by Sidedness (Bevacizumab)<br /> Presented By Alan Venook at 2016 ASCO Annual Meeting

30 80405: OS by Sidedness (Cetuximab)<br /> Presented By Alan Venook at 2016 ASCO Annual Meeting

31 80405: Sidedness is Prognostic<br /> Overall Survival (OS) Presented By Alan Venook at 2016 ASCO Annual Meeting

32 80405: Overall Survival by Sidedness and Biologic Presented By Alan Venook at 2016 ASCO Annual Meeting

33 Venook et al: Major findings Presented By Kimmie Ng at 2016 ASCO Annual Meeting

34 Sidedness = Biological Surrogate BRAF mutations right sided not enough to explain Transcriptional Subtypes Hypermethylation Immunological Effects Environment (microbiome) - fusobacterium

35 80405: Exploratory Analysis (wt v mut )<br /> Presented By Alan Venook at 2016 ASCO Annual Meeting

36 More than two sides to this story Presented By Kimmie Ng at 2016 ASCO Annual Meeting

37 Sidedness in mcrc Sidedness is a surrogate for tumor biology Side of origin matters Right or left side is effectively a biomarker Clinical trials need to stratify Right or Left

38 80405 Sidedness Take Home Data supports bevacizumab for frontline therapy of metastatic colorectal cancer patients with right sided tumors regardless of kras status

39 ASCO 2016 Highlights: Practice Change 2016 Practice Change 2017 Practice Consideration Expansion of MSI deficient histologies Immunotherapy Potential in Rare but Real Cancer

40 PD-1 Blockade in Mismatch Repair Deficient Cancer Independent of Tumor Histology Presented By Lawrence Fong at 2016 ASCO Annual Meeting

41 Mismatch Repair Deficiency Presented By Dung Le at 2015 ASCO Annual Meeting

42 Associated tumor types Presented By Dung Le at 2015 ASCO Annual Meeting

43 Slide 8 Presented By Dung Le at 2015 ASCO Annual Meeting

44 Slide 10 Presented By Dung Le at 2015 ASCO Annual Meeting

45 Slide 13 Presented By Dung Le at 2015 ASCO Annual Meeting

46 Slide 12 Presented By Lawrence Fong at 2016 ASCO Annual Meeting

47 Conclusions: Beyond Histology MMR deficient tumors across different histologies responsive Testing for MSI is accessible and available Results for MSI-H patients (CRC and non colorectal) are impressive and durable Select patients for immunotherapy based on molecular defect regardless of tissue of origin

48 ASCO 2016 Highlights: Practice Change 2016 Practice Change 2017 Practice Consideration Practice Status Quo Expansion of MSI H opportunities Immunotherapy Potential in Rare but Real Cancer Anal Squamous Cell Carcinoma and Nivolumab

49 NCI9673: A Multi-Institutional ETCTN Phase II Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal (SCCA) Presented By Van Morris at 2016 ASCO Annual Meeting

50 SCC of Anal Canal 2016: 8,080 new diagnoses in US 1,080 deaths 27,000 new cases annually worldwide No established standard of care in metastatic setting NCCN cisplatin-based chemotherapy

51 Rationale for Nivolumab in Metastatic SCCA: Presented By Van Morris at 2016 ASCO Annual Meeting

52 NCI9673: Primary Endpoint of Response Rate Presented By Van Morris at 2016 ASCO Annual Meeting

53 Anal SCC and Nivolumab First prospective Phase II study completed in metastatic refractory setting Single agent Nivolumab well tolerated No SAEs in HIV + patients Met primary endpoint of response Response rate of 24% - 37 ITT 34 evaluable patients: 7 PR and 2 CR

54 GI 2016 Thematic Questions Remain How will further subtyping of tumors allow for personalized selection of therapies? What role will immunotherapy play in the management of gastrointestinal cancers?

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